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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 May 2015
Main ID:  NCT02306629
Date of registration: 29/11/2014
Prospective Registration: No
Primary sponsor: UCB Biopharma S.P.R.L.
Public title: Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
Scientific title: An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects
Date of first enrolment: November 2014
Target sample size: 42
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02306629
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United Kingdom
Contacts
Name:     UCB Clinical Trial Call Center
Address: 
Telephone:
Email:
Affiliation:  +1 877 822 9493 (UCB)
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject is male or female.

- At the Screening Visit, subject is 18 years to 50 years, inclusive (for Caucasian
subjects), or 20 years to 50 years (for Japanese subjects)

- Subject must be in good health (physically and mentally) as determined by the
investigator on the basis of medical history

- Subject has a body weight of 45 kg to 90 kg, inclusive, and body mass index (BMI)
between 18.0 kg/m2 and 29.9 kg/m2, inclusive

- Japanese subjects are defined as a person carrying a Japanese passport, who is a
descendant of 4 Japanese grandparents and has not been outside Japan for more than 5
years prior to screening

- Females of childbearing potential are required to have a negative serum pregnancy
test at the Screening Visit and must agree to use an acceptable method of birth
control during the study and for a period of 3 months after the administration of
investigational medicinal product (IMP)

- Male subjects must agree to use an acceptable method of contraception during the
study and for at least 3 months after receiving IMP unless they have undergone
vasectomy

Exclusion Criteria:

- Subject has donated blood (including through participation in another clinical study)
or suffered blood loss (=450 mL) <60 days prior to dosing, or has donated platelets
<14 days prior to dosing

- Subject has active malignancies or a history of malignancy

- Subject has a history of severe or multiple allergies

- Subject has a history of chronic infection, recent serious or life-threatening
infection

- Subject with a recurrent history or active systemic/respiratory infection due to
fungal, parasitic, or mycotic pathogens

- Subject has a positive HBsAg, anti-HCV or anti-HIV test result during the Screening
Period

- Subject has a history of or a concurrent clinically significant illness, medical
condition, or laboratory abnormality that, in the investigator's opinion, could
affect the safety of the subject upon exposure to epratuzumab or confound the results
of the study

- Female subjects who are breast feeding, pregnant, or plan to become pregnant during
the study or within 3 months following dosing of the IMP

- Subjects who are immunocompromised

- A confirmed positive urine drug screen

- Subject has a history of substance abuse, drug addiction, or alcoholism within 3
years prior to study admission

- Subject is unable or unwilling to stop smoking during the inpatient stay

- Subject has previous exposure to, or has participated in studies with, any other
anti-B-cell therapies

- Subject has a medical condition that requires chronic medication

- Subject has received a live vaccine in the month prior to the administration of IMP
or is scheduled or expected to receive live vaccines during the study period or for 3
months after administration of the IMP



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus
Intervention(s)
Biological: Epratuzumab iv
Biological: Epratuzumab sc
Primary Outcome(s)
Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf)) [Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)]
Absolute bioavailability of the tested single sc doses [Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)]
Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t)) [Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)]
Maximum observed plasma concentration (Cmax) [Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)]
Secondary Outcome(s)
Apparent terminal half-life (t½) [Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)]
Time of observed Cmax (tmax) [Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)]
Secondary ID(s)
SL0032
2014-000911-15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
The Doctors Laboratory
Eurofins Pharma Bioanalysis
Pharmaceutical Research Associates
ACM Global Europe
Richmond Pharmacology Limited
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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